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ENALAPRIL MALEATE/HYDROCHLOROTHIAZIDE 20/12.5MG TABLETS

Active substance(s): ENALAPRIL MALEATE / HYDROCHLOROTHIAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Enalapril maleate/Hydrochlorothiazide
20/12.5 mg Tablets

SZ00000LT000

enalapril maleate, hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Enalapril maleate/Hydrochlorothiazide 20/12.5 mg
Tablets are and what they are used for
2. Before you take Enalapril maleate/Hydrochlorothiazide
20/12.5 mg Tablets
3. How to take Enalapril maleate/Hydrochlorothiazide
20/12.5 mg Tablets
4. Possible side effects
5. How to store Enalapril maleate/Hydrochlorothiazide
20/12.5 mg Tablets
6. Further information

1

What Enalapril maleate/Hydrochlorothiazide
20/12.5 mg Tablets are and what they are
used for

Enalapril belongs to a group of medicines called angiotensin
converting enzyme inhibitors (ACE inhibitors) and lowers blood
pressure by widening the blood vessels.

Hydrochlorothiazide belongs to a group of drugs called diuretics
(“water tablets”) and lowers blood pressure by increasing urine output.
Your doctor may prescribe Enalapril maleate/Hydrochlorothiazide
tablets instead of separate tablets of the same doses of enalapril
and hydrochlorothiazide.
This fixed dose combination is not suitable for initial therapy.

Enalapril maleate/Hydrochlorothiazide tablets contain a
combination of enalapril and hydrochlorothiazide and are used as
a treatment for high blood pressure when treatment with enalapril
as a single agent on its own has proven insufficient.

Do NOT take Enalapril maleate/Hydrochlorothiazide:
• if you are allergic (hypersensitive) to enalapril maleate,
hydrochlorothiazide or any of the other ingredients of this medicine
• if you are allergic (hypersensitive) to sulphonamide-derived
medicines (mostly antibiotics e.g. sulphamethoxazole)
• if you have previously suffered from swelling of the extremities,
face, lips, throat, mouth or tongue (angioedema) when treated
with other medicines belonging to a group of drugs called ACE
inhibitors (angiotensin-converting enzyme inhibitors)
• if you have previously suffered from swelling of the extremities,
face, lips, throat, mouth or tongue (angioedema) under any
other circumstances
• if anyone among your blood relatives has previously suffered
from swelling of the extremities, face, lips, throat, mouth or
tongue (angioedema)
• if you have severe kidney problems
• if you are not passing urine
• if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing aliskiren
• if you have severe liver problems or a neurological disorder as
a result of severe liver problems (hepatic encephalopathy)
• if you are more than 3 months pregnant. (It is also better to
avoid Enalapril maleate/ Hydrochlorothiazide in early
pregnancy - see pregnancy section).
Warnings and precautions
Talk to your doctor before taking this medicine
• if you have narrowing of the arteries (atherosclerosis),
cerebrovascular problems such as a stroke or transient
ischemic attack (TIA, a “mini-stroke”)
• if you suffer from a disease, distinguished by reduced blood
supply of the heart muscle, usually due to coronary blood
vessel diseases (ischemic heart disease)
• if you have heart failure
• if you have low blood pressure, are on a salt restricted diet or
are taking diuretics (“water tablets”)
• if you have abnormal levels of water and minerals in your body
(fluid/electrolyte imbalance) distinguished by nausea,
abdominal cramping, and/or vomiting, headache, edema
(swelling), muscle weakness and/or tremor amongst others
• if you have heart muscle disease (hypertrophic cardiomyopathy),
a narrowing of the main artery carrying blood away from the
heart, the aorta (aortic stenosis), or a narrow of the artery to
the only functioning kidney, have a kidney transplantation or
other forms of a heart problem called outflow obstruction
• if you undergo LDL apheresis (removal of cholesterol from the
blood by a machine)
• if you undergo desensitization therapy to some insect venoms,
such as bee or wasp stings
• if you have diabetes
• if you suffer from gout, have high levels of uric acid in your
blood or are being treated with allopurinol
• if you need to have an anesthetic
• if you have recently suffered from prolonged, violent vomiting
and/or serious diarrhoea
• if you are going to have tests to check your parathyroid function
• if you have or have had liver or kidney problems, or you have
narrow arteries to your kidneys (renal artery stenosis) or only
have one functioning kidney, or you are undergoing dialysis
• if you have collagen vascular disease such as systemic lupus
erythematosus (SLE) or scleroderma, which may be
associated with skin rashes, joint pain and fever
• if you take an agent capable of suppressing immune re
sponses (immunosuppressant) or procainamide, which is used
to treat heart rhythm disturbances amongst others
• if you have allergy problems or asthma.
• if you are taking lithium, used for the treatment of some
psychiatric illness
• if you are taking any of the following medicines used to treat
high blood pressure:
− an angiotensin II receptor blocker (ARBs) (also known as
sartans - for example valsartan, telmisartan, irbesartan), in
particular if you have diabetes-related kidney problems.
− aliskiren
Your doctor may check your kidney function, blood pressure, and
the amount of electrolytes (e.g. potassium) in your blood at
regular intervals.
See also information under the heading “Do not take Enalapril
maleate/Hydrochlorothiazide”.
You must tell your doctor if you think you are (or might become)
pregnant. Enalapril maleate/Hydrochlorothiazide is not
recommended in early pregnancy, and must not be taken if you
are more than 3 months pregnant, as it may cause serious harm
to your baby if used at that stage (see pregnancy section).
Breast-feeding is not recommended when you take Enalapril
maleate/Hydrochlorothiazide.

Enalapril maleate/Hydrochlorothiazide is not generally
recommended if the following apply, so talk to your doctor before
starting to take this medicine:
• if you have recently had a kidney transplant
• if you have too much potassium in the blood, your potassium
values should be supervised during the treatment. Risk factors
for raised potassium values include a reduced kidney function,
age (> 70 years), dehydration, acute heart failure, acidification
of the blood (metabolic acidose), diabetes (diabetes mellitus),

concurrent taking of potassium sparing water tablet (diuretic),
a potassium supplement or potassium-containing salt
substitutes or taking medicines that increase the concentration
of potassium in the blood. It is also possible that you can
develop low levels of potassium in your blood distinguished by
elevated blood pressure, disturbed heart rhythm etc. (e.g. to
be caused by drug interactions, excessive loss of urine etc.).

Please refer also to “Other medicines and Enalapril maleate/
Hydrochlorothiazide” below.
Talk to your doctor if you are an athlete taking a doping test, as
Enalapril maleate/Hydrochlorothiazide contains an active
ingredient that can cause positive results in a doping test.
Elderly (> 70 years) or malnourished patients should be
particularly careful when using Enalapril maleate/
Hydrochlorothiazide.
Enalapril maleate/Hydrochlorothiazide may be less effective in
Black people.
This medicine is not recommended for use in children.

While taking Enalapril maleate/Hydrochlorothiazide if you develop
any of the following symptoms you should let your doctor know
immediately:
• you feel dizzy after your first dose. A few people react to their
first dose or when their dose is increased by feeling dizzy,
weak faint and sick
• sudden swelling of the lips and face neck, possibly also hands
and feet, or wheezing or hoarseness. This condition is called
angioedema. This may occur at any time during treatment.
ACE inhibitors cause a higher rate of angioedema in black
patients than in non-black patients
• high temperature, sore throat or mouth ulcers (these may be
symptoms of infection caused by the lowering of the number of
white blood cells)
• yellowing of the skin and whites of eyes (jaundice) that may be
sign of liver disease
• a dry cough which is persistent for a long time. Cough has
been reported with the use of ACE inhibitors but may be also a
symptom of other upper respiratory track disease.

Other medicines and Enalapril maleate/Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Enalapril maleate/Hydrochlorothiazide and other medicines can
influence each otherʼs effect and side effects:
• potassium supplements, or potassium-containing salt substitutes
• diuretics (“water tablets”) which are used to treat high blood
pressure including potassium-sparing diuretics such as
spironolactone, triamterene or amiloride.
• other medicines used to treat high blood pressure.
Your doctor may need to change your dose and/or to take
other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or
aliskiren (see also information under the headings “Do not take
Enalapril maleate/Hydrochlorothiazide” and “Warnings and
precautions”).
• anesthetics and medicines for mental disorders or
depressions, medicines to treat psychoses, tricyclic antide
pressants or sedatives
• lithium (medicine for treatment of psychic disorders)
• painkillers and anti-inflammatory medicines, such as
acetylsalicylic acid or indomethacin
• gold injections (sodium aurothiomalat), a medicine to injection
against rheumatic arthritis
• medicines such as ephedrine, used in some cough and cold
remedies, or noradrenaline and adrenaline used for low blood
pressure, shock, cardiac failure, asthma or allergies
• blood sugar lowering medicines, such as insulin or those taken
orally
• colestyramine resin and colestipol, active substances for
lowering blood lipid values
• corticosteroids, anti-inflammatory hormone-like substances
• corticotropin (ACTH), it is used mainly to test whether your
adrenal glands are working properly
• muscle relaxants (e.g. tubocurarine chloride, medicines for
relaxing muscles that are used in operations)
• allopurinol, probenecide, sulfinpyrazone, medicinal products
used to treat gout
• medicines such as atropine or biperiden which are used to
treat a variety of disorders such as gastrointestinal cramps,
urinary bladder spasm, asthma, motion sickness, muscular
spasms and as an aid to anaesthesia
• medicines to treat cancer, such as cyclophosphamide or
methotrexate
• medicines that inhibit your bodyʼs immune system, medicines
to prevent rejection reactions after organ or bone marrow
transplants such as ciclosporin
• cardiac glycosides (e.g. digoxin, medicines for strengthening
the heart)
• medicines that as a side effect may cause abnormalities in the
stimulus conduction in the heart such as medicines for
disturbances for heart rhythm, some medicines for psychosis
and other medicines such as drugs used to treat bacterial infections
• calcium salts and vitamin D, elevated calcium levels in the
blood (can lead to gastrointestinal disorders, excessive thirst,
excessive urination, tiredness, weakness and decrease in weight)
• carbamazepine, drug used primarily in the treatment of
epilepsy and bipolar disorder
• amphotericin B, medicines against fungal infections
• laxatives, medicines to promote defection
• iodinated contrast media, enhances the visibility of vascular
structures and organs during radiographic procedures
• barbiturates, medicines that act as central nervous system
depressant resulting in sedation
• opioid analgesics, strong pain killers with no anti-inflammatory
effect
• carbenoxolone, medicine to treat inflammation of the intestinal tract
• salicylates, medicines to treat pain and/or inflammatory diseases.
Taking Enalapril maleate/Hydrochlorothiazide with food and drink
Enalapril maleate/Hydrochlorothiazide can be taken without
regard to meals. Drinking alcohol together with this medicine can
increase the blood pressure-lowering effect (and can then cause
dizziness on standing up, among other things).

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Enalapril maleate/Hydrochlorothiazide before you become
pregnant or as soon as you know you are pregnant and will
advise you to take another medicine instead of Enalapril
maleate/Hydrochlorothiazide.

Continued on the next page >>

Enalapril maleate/Hydrochlorothiazide is not recommended in
early pregnancy, and must not be taken when more than 3
months pregnant, as it may cause serious harm to your baby if
used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start
breast-feeding. Enalapril maleate/Hydrochlorothiazide is not
recommended for mothers who are breast-feeding.

Driving and using machines
Dizziness and tiredness have been reported by people taking
Enalapril maleate/Hydrochlorothiazide. If you experience either of
these do not drive a car and do not operate machinery (see also
“4. Possible side effects”).

Important information about some of the ingredients of
Enalapril maleate/Hydrochlorothiazide
Patients who are intolerant to lactose should note that Enalapril
maleate/Hydrochlorothiazide tablets contain a small amount of
lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.

3

How to take Enalapril maleate/
Hydrochlorothiazide 20/12.5 mg Tablets

Always take Enalapril maleate/Hydrochlorothiazide exactly as
your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Adults
The usual dose is one tablet taken once a day.

Elderly
Your doctor may adjust the dose of enalapril and
hydrochlorothiazide carefully.
Kidney problems
Your doctor will adjust the dose of enalapril and
hydrochlorothiazide carefully.

If you are currently taking other diuretic tablets (water tablets) you
should stop taking them 2-3 days before starting to take Enalapril
maleate/Hydrochlorothiazide 20/12.5 mg Tablets.
Method of administration
The tablets should be swallowed with a drink of water.
Enalapril maleate/Hydrochlorothiazide can be taken with a meal
or on an empty stomach.

The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.

If you take more Enalapril maleate/Hydrochlorothiazide than
you should
If you (or someone else) swallow a lot of the tablets all together,
or if you think a child has swallowed any of the tablets, seek
medical advice immediately. An overdose is likely to cause low
blood pressure, an excessively fast or slow heart beat,
palpitations (a feeling of unduly rapid or irregular heart beat),
shock, rapid breathing, cough, feeling and being sick, cramps,
dizziness, feeling sleepy and confused or anxious, excessive
urination or not being able to urinate. Please take this leaflet, any
remaining tablets and the container with you to the hospital or
doctor so that they know which tablets were consumed.
If you forget to take Enalapril maleate/Hydrochlorothiazide
Do not take a double dose to make up for a forgotten tablet, take
your next dose at the normal time.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
If you stop taking Enalapril maleate/Hydrochlorothiazide
The treatment of hypertension is a long term treatment and
interruption of treatment must be discussed with the doctor.
Interruption or stopping your treatment could cause your blood
pressure to increase.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4

Possible side effects

Like all medicines, Enalapril maleate/Hydrochlorothiazide can
cause side effects, although not everybody gets them.

If you experience the following, stop taking Enalapril
maleate/Hydrochlorothiazide and tell your doctor
immediately or go to the emergency department of your
nearest hospital:
• a severe allergic reaction called angioedema (rash, itching,
swelling of the extremities, face, lips, mouth or throat that may
cause difficulty in swallowing or breathing). This is a serious
and common (affecting more than 1 out of 100 patients and
less than 1 out of 10 patients) side effect. You may need
urgent medical attention or hospitalisation.
• jaundice (yellowing of the skin and the whites of the eyes).
This is a potentially serious but rare (affecting more than 1 out
of 10,000 patients and less than 1 out of 1,000 patients) side
effect indicative of inflammation of the liver. You may need
urgent medical attention or hospitalisation.

Enalapril maleate/Hydrochlorothiazide commonly causes low
blood pressure which may be associated with feelings of
light-headedness and weakness. In some patients, this may occur
after the first dose or when the dose is increased. If you
experience these symptoms, you should contact your doctor
immediately.

Enalapril maleate/Hydrochlorothiazide rarely causes a reduction
in the number of white blood cells and your resistance to infection
may be decreased. If you experience an infection with symptoms
such as fever and serious deterioration of your general condition,
or fever with local infection symptoms such as sore throat/
pharynx/mouth or urinary problems you should see your doctor
immediately. A blood test will be taken to check possible reduction
of white blood cells (agranulocytosis). It is important to inform your
doctor about your medicine.
A dry cough, which may persist for a long time, has been reported
very commonly (in more than 1 out of 10 patients) with the use of
Enalapril maleate/Hydrochlorothiazide and other ACE inhibitors,
but may be also a symptom of other upper respiratory tract
disease. You should contact your doctor if you develop this
symptom.
The following side effects have also been reported:
Very common (more than 1 out of 10 patients)
• blurred vision
• dizziness
• nausea
• weakness.

Common (more than 1 out of 100 patients and less than 1 out
of 10 patients)
• low levels of potassium in the blood, which can cause muscle
weakness, twitching or abnormal heart rhythm
• high level of fat or uric acid in the blood
• headache, depression
• fainting, low blood pressure associated with changes in
posture (such as feeling light-headed or weak when you stand
up after lying down), chest pain, abnormal heart rhythm,
excessively fast heart beat (tachycardia)
• shortness of breath
• diarrhoea, abdominal pain
• a distorted sense of taste
• rash
• tiredness
• high level of potassium in the blood, which can cause an
abnormal heart rhythm; increase in the amount of creatinine in
the blood
• muscle cramps.

Uncommon (more than 1 out of 1,000 patients and less than 1
out of 100 patients)
• reduction in the number of red blood cells, which can make the
skin pale and cause weakness or breathlessness (anaemia)
• hypoglycaemia (low blood sugar levels) (see “Take special
care with Enalapril maleate /Hydrochlorothiazide” in section 2)
• low level of magnesium in the blood
• uric acid crystals in the joints (gout)
• confusion, sleepiness, insomnia, nervousness, tingling feeling
or numbness, vertigo, decreased sexual desire
• palpitations (a sensation of a fast or particularly strong or
irregular heart beat)
• heart attack or cerebrovascular accident (“mini-stroke”) (mainly
in patients suffering from low blood pressure)
• runny nose, sore throat, hoarseness, difficulty breathing,
wheezing
• intestinal obstruction, inflammation of the pancreas which
causes severe pain in the abdomen and back (pancreatitis),
vomiting, indigestion, constipation, loss of appetite, stomach
irritation, dry mouth, peptic ulcer, flatulence
• sweating, itching, hives, hair loss
• joint pain
• kidney problems, protein in the urine
• impotence
• hot flushes, ringing in the ears
• feeling unwell, fever
• low levels of sodium in the blood, which can cause tiredness
and confusion, muscle twitching, fits or coma, also leading to
dehydration and low blood pressure that makes you feel dizzy
when you stand up; increase in the amount of urea in the blood.
Rare (more than 1 out of 10,000 patients and less than 1 out
of 1,000 patients)
• reduction in the number of white blood cells, which makes
infection more likely, reduction in the number of other blood
cells, changes in blood composition, poor production of bone
marrow, disease of the lymph nodes, autoimmune disease, in
which the body attacks itself
• strange dreams, sleep disorders
• paresis
• Raynaudʼs syndrome, a blood vessel disorder which may
cause your fingers and toes to tingle, and turn pale, then
bluish, then reddish
• lung problems including pneumonia, inflammation of the lining
of the nose causing the nose to run (rhinitis)
• mouth ulcers, inflammation of the tongue
• liver problems, inflammation of the gallbladder
• skin rash, severe blisters, redness of the skin, Stevens
Johnson syndrome (blistering of the skin, mouth, eyes and
genitals), skin looking as if it were burnt and peeling off,
sensitivity of the skin to light, skin conditions with red scaly
patches over the nose and cheeks (lupus erythematosus)
pemphigus (a condition causing blisters and lesions normally
starting in the mouth, nettle rash, hair loss and itching).
Sometimes, skin problems may be accompanied by fever,
serious inflammation, inflammation of blood vessels, muscle
pain and/or joint pain, changes in blood composition and an
increased sedimentation rate (a blood test used to detect
inflammation)
• reduced urine production
• inflammation in the kidneys (interstitial nephritis)
• breast enlargement including in men
• increase in the amount of enzymes and waste products
produced by the liver
• increased blood sugar levels.

Very rare (less than 1 out of 10,000 patients)
• swelling in the intestines
• high levels of calcium in the blood (see “Take special care with
Enalapril maleate /Hydrochlorothiazide” in section 2).
Not known (cannot be estimated from available data)
• inappropriate antidiuretic hormone secretion (known as
SIADH) causing amongst others the general symptoms
confusion, nausea, altered mood, seizures and loss of
consciousness.

Further side effects:
• inflammation of a salivary gland
• excretion of glucose into the urine (glycosuria)
• decreased appetite, light-headedness
• predominance of yellow in vision due to a yellowing of the optic
media of the eye (xanthopsia).
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5

How to store Enalapril maleate/
Hydrochlorothiazide 20/12.5 mg Tablets

Keep out of the reach and sight of children.

Store in the original package in order to protect from light and
moisture.

Do not use Enalapril maleate/Hydrochlorothiazide 20/12.5 mg
Tablets after the expiry date which is stated on the label after
EXP:. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the
environment.

6

Further information

What Enalapril maleate/Hydrochlorothiazide 20/12.5 mg
Tablets contains
The active substances are:
enalapril maleate and hydrochlorothiazide.
Each tablet contains 20 mg of enalapril maleate and 12.5 mg of
hydrochlorothiazide.
The other ingredients are:
sodium hydrogen carbonate, lactose monohydrate, maize starch,
pregelatinised starch, talc and magnesium stearate
What Enalapril maleate/Hydrochlorothiazide 20/12.5 mg
Tablets look like and contents of the pack
Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg tablets are
white, round, one-side scored tablets with bevelled edges.
The tablets are packed in aluminium/polyamide/aluminium/PVC
blisters and inserted into a carton.
The tablets are supplied in packs of 10, 28, 30, 50, 56, 98, 100
tablets and 100 (100 x 1) unit dose.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer:
Salutas Pharma GmbH, Otto von Guericke Allee 1,
39179 Barleben, Germany. or Salutas Pharma GmbH,
Dieselstraße 5, D-70839 Gerlingen, Germany
This leaflet was last revised in 08/2014.

draft: 990576
laetus code: supplier to add
mat.no.: supplier to add

SZ00000LT000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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